Differentiating Type 1 and Type 2 Diabetes Mellitus
An estimated 422 million people across the world are living with diabetes1. Diabetes Mellitus (DM) encompasses a collection of chronic diseases characterised by absent or ineffective insulin activity. Insulin is a hormone produced by the pancreas responsible for a host of essential physiological processes related to glucose metabolism and protein synthesis.
There are two main forms of DM, named type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which result from different mechanisms and more importantly, require different therapeutic approaches. It is estimated that up to 40% of those diagnosed with T1DM after the age of 30 may have been misdiagnosed with T2DM2. This misdiagnosis of T1DM as T2DM will result in poor glycaemic control, frequent healthcare contact for increased treatment, inappropriate insulin regimes and risk of life-threatening ketoacidosis.
In this article, we’ll look at the similarities and differences between these two forms of DM and investigate the mechanisms by which these common diseases arise.
Insulin Pathway
The normal insulin signalling pathway, shown below, is responsible for the processing and transport of glucose in the body. Briefly, insulin binds to the insulin receptor and activates PI3K and, subsequently, serine-threonine kinase (AKT). AKT is responsible for the phosphorylation of glycogen synthase kinase 3-β (GSK-3β), inhibiting its activity and promoting the synthesis of glycogen leading to a reduction in blood glucose concentration. Failing to inhibit GSK-3β will result in hyperglycaemia and eventually T2DM.
Type 1 Diabetes Mellitus
T1DM is most commonly diagnosed at a young age. This form of DM is the result of an autoimmune reaction to proteins produced by the pancreas which results in a lack of insulin secretion. The antibodies responsible for this autoimmunity are detailed in the table below:
A key factor in T1DM pathogenesis is changes in the T cell-mediated immunoregulation, notably in the CD4+ T cell compartment. The activation of the CD4+ T cells is responsible for inflammation of the pancreatic cells which produce insulin, known as insulitis.
Changes in the expression of IL-1 and TNFα cause structural alterations in pancreatic β-cells which result in the suppression of insulin secretion. This insulin deficiency has subsequent effects on glucose metabolism and protein synthesis.
T1DM causes an increase in hepatic glucose levels when gluconeogenesis converts glycogen to glucose. A lack of insulin means the subsequent hepatic uptake of this glucose does not occur.
Insulin is also responsible for regulating the synthesis of many proteins. This regulation can be positive or negative but ultimately results in an increase in protein synthesis and a decrease in protein degradation. Therefore, when hypoinsulinemia occurs, decreasing insulin concentration in the blood, protein catabolism is increased leading to increased plasma amino acid concentration.
Type 2 Diabetes Mellitus
The pathogenesis of T2DM, detailed in the diagram below, is multi-factorial. It arises from a combination of genetic and environmental factors which affect insulin activity.
In T2DM, the regulatory mechanisms related to glucose metabolism fail resulting in impaired insulin activity or insulin resistance.
Mutations in genes involved in insulin production can cause the secretion of abnormal insulin molecules, known as insulinopathies. Insulinopathies are unable to effectively metabolise glucose which results in the accumulation of this sugar. Additionally, obesity is considered to be a causal factor in the development of T2DM.
Unlike those with T1DM, patients with T2DM can maintain circulating insulin levels. T2DM is characterised by glucose intolerance, impaired glucose tolerance, diabetes with minimal fasting hyperglycaemia, and DM in association with overt fasting hyperglycaemia.
Individuals with impaired glucose tolerance have hyperglycaemia despite preserving high levels of plasma insulin. These levels of insulin decline from impaired glucose tolerance to DM. It is insulin resistance is considered the primary cause of T2DM.
Misdiagnosis
The misdiagnosis of these types of DM is common, due to similar symptoms. The simplest differentiating factor is when these symptoms manifest. T1DM is an autoimmune disorder and therefore, symptoms generally occur much earlier in one’s life. T2DM is typically diagnosed in later life. The common symptoms of DM are:
- Frequent urination, particularly throughout the night.
- Polydipsia (excessive thirst)
- Polyphagia (excessive hunger)
- Lethargy
- Sudden weight loss
- Genital itching or thrush
- Blurred vision
The misdiagnosis of T2DM as T1DM results in unnecessary initial insulin therapy, higher drug and monitoring costs and often, an increase in the number and severity of symptoms. Conversely, the incorrect classification of T1DM as T2DM causes poor glycaemic control, frequent visits to healthcare services for treatment, inappropriate insulin regimes and risk of Diabetic Ketoacidosis.
Diabetic Ketoacidosis (DKA)
DKA is a potentially life-threatening condition caused by an accumulation of ketones in the body due to insulin deficiency, which is common in patients with T1DM, however, an increasing number of cases have been reported in patients with T2DM. Diagnosis of DKA consists of a high anion gap metabolic acidosis, ketone bodies present in serum and/or urine, and high blood glucose concentration. The symptoms of DKA include:
- Polyuria (excessive urination) and polydipsia (thirst)
- Weight loss
- Fatigue
- Dyspnoea (shortness of breath)
- Vomiting
- Fever
- Abdominal pain
- Polyphagia (excess hunger)
- Fruity-smelling breath caused by acetone accumulation.
Randox Type 1 Diabetes Mellitus Genetic Risk Array
T1DM is largely genetic and is associated with over 50 distinct genetic signatures, many of which are single nucleotide polymorphisms (SNPs). This is of great advantage in testing as unlike traditional biomarkers, genetic markers don’t change throughout one’s life, providing a robust method for diagnosis and risk stratification. Genetic data gathered can then be used to develop a genetic risk score, allowing an individual’s probability of developing the disease to be quantified.
Using this principle, together with our patented Biochip array technology, Randox have developed a T1DM GRS array. Using a combination of 10 SNPs from the HLA region and the non-HLA region commonly detected in T1DM patients, and a selection of other risk factors and biomarkers, this molecular array can accurately discriminate between T1DM and T2DM.
Conclusions
Misdiagnosis of DM can have life-threatening consequences. Both types of DM are very common and distinguishing between T1DM and T2DM is crucial.
T1DM is an autoimmune disorder with a lack of insulin secretion, while T2DM is primarily due to insulin resistance. Understanding their mechanisms is vital for accurate diagnosis and treatment. Genetic testing, like the Randox Type 1 Diabetes Mellitus Genetic Risk Array, can differentiate between T1DM and T2DM by analysing genetic markers and providing personalized treatment insights.
Accurate diabetes diagnosis is crucial for proper management, prevention of complications, and improving the lives of millions. Together, we can make a difference in the lives of those affected by diabetes!
If you’d like to learn more about the different types of DM, including the pathogenesis, pathophysiology, associated risk factors, and more, please take a look at our educational guide Diabetes Solutions.
Alternatively, feel free to reach out to our marketing team at marketing@randox.com who will be happy to help you with any queries you may have.
References
- World Health Organization. Diabetes. World Health Organisation. Published April 5, 2023. Accessed April 25, 2023. https://www.who.int/news-room/fact-sheets/detail/diabetes
- The Misdiagnosis of type 1 and type 2 diabetes in adults. The Lancet Regional Health. 2023;29:100661-100661. doi:https://doi.org/10.1016/j.lanepe.2023.100661
World Haemochromatosis Awareness Week
World Haemochromatosis Awareness Week, took place this year between theĀ 1st ā 7th June.
Genetic Haemochromatosis, or the āCeltic Curseā is the UK and Ireland’s most inherited condition.
Randox can help you find out if you are at risk with a blood test from one of our Randox Health clinics, including our newly opened Clinic in Sandyford, Dublin.
The tests are available from Ā£69 and the results of which will be returned within 7-14 days. Randoxās easy-to-interpret Genetic Haemochromatosis risk report will provide a breakdown of your results and what they mean.
An optional remote appointment with a Randox genetic counsellor can also be made when booking. Early diagnosis enables early treatment to prevent ill health because of iron overload.
Haemochromatosis is a condition which causes people to absorb too much iron from their diets but many people are not aware of it despite over 9 million people in the UK estimated to have the genetic predisposition to haemochromatosis (or Iron overload disorder.)
Despite its commonplace, this condition is rarely diagnosed with only one in every five thousand receiving a diagnosis.
Symptoms can Include:Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā Ā
ā¢Ā Fatigue
ā¢ Palpitations
ā¢ Joint Pain
ā¢ Abdominal Pain
ā¢ Skin PigmentationĀ Ā
Haemochromatosis is an Autosomal Recessive disorder.
These type of disorders usually mean that men and women are equally likely to be affected, with Haemochromatosis however, men are more likely to be at risk than women.Ā
Women may be protected from iron overload due to physiological blood loss (menstruation and pregnancy) which can reduce theĀ iron overload.
Men living with haemochromatosis are ten-times more likely to be at risk of liver cancer and have twice the risk of developing dementia, if left undiagnosed or untreated.
Follow the link below to book: Haemochromatosis Test
ADLM 2024
At the Forefront of the Diagnostics Industry
With more than forty years of expertise in the medical diagnostics field, Randox is committed to improving global health outcomes. Renowned for its high-quality diagnostic solutions, Randox provides an extensive array of products and services, including Quality Control, Molecular Diagnostics, Third Party Reagents, Point of Care, and Clinical Chemistry Analysers.
Pushing Innovation to the Limits
At Randox, innovation is our cornerstone. Our recent release of Acusera SMART exemplifies our dedication to advancing medical diagnostics. This development integrates seamlessly with various test systems, streamlining the QC process by reducing human error and optimising workflow. Additionally, we’ve launched new Acusera Quality Controls, including active B12, serum indices, and ultra-low PSA, along with comprehensive panels on our MultiStat platform, now expanded to include gastrointestinal diseases, bladder cancer, and male and female hormones. These advancements ensure accurate and reliable diagnostic results, reflecting our commitment to delivering cutting-edge solutions for the evolving healthcare industry.
Learn more about the products we will be showcasing by clicking on the images to the left.
Dedicated to Improving Health Worldwide
With over four decades of experience in the medical diagnostics industry, Randox is dedicated to enhancing global health outcomes. As a provider of high-quality diagnostic solutions, Randox offers a wide range of products and services, including Quality Control, Molecular Diagnostics, Third Party Reagents, Point of Care, and Clinical Chemistry Analysers.
Acusera Quality Controls
Introducing the New Acusera True Third Party Controls. Book a meeting with a Randox QC Specialist today to learn how we can provide you with complete QC solutions for results you can trust.
Molecular Diagnostics at the Point of Care
The all in one molecular solution developed by Bosch and Randox consolidates full molecular workflow into one small benchtop platform. Randox multiplex Biochip Technology powers the Vivalytic enabling multiple results from one patient sample. Click the link below to learn more about the Vivalytic.
ACUSERA 24•7 Interlaboratory Data Management
Discover features such as; Interactive Levey-Jennings Charts, Automatic Calculation for uncertainty of Measurement as well as the Comprehensive Reports generated on demand, with a live demonstration at EuroMedLab.
RIQAS
The world’s largest External Quality Assessment Scheme with more than 55,000 laboratory participants spanning over 134 countries. Choice and flexibility are guaranteed with our 36 programme portfolio, learn more by clicking the button below!
Contract Manufacturing
At Randox, we are dedicated to helping you bring your diagnostic and life science products to market with unparalleled expertise, capacity, and commitment to quality. With over 40 years of experience and a network of over 300 global customers, our comprehensive OEM and contract manufacturing services cover the entire value chain, from concept development to full commercialisation.
Meet The Team
If you plan to attend ADLM 2024, our Product Specialists Team will be available at Booth #1413 to answer any questions you may have. To ensure the most productive use of your time, we recommend scheduling a meeting with one of our Randox representatives in advance to discuss your specific needs and book a time slot during the event.
Vivalytic | Bordetella
Vivalytic | Bordetella
–
Detection of B. pertussis, B. parapertussis, B. holmesii
Qualitative RT-PCR detection of Bordetella Species
- Quick turnaround time of 47 minutes, beneficial for both the patient and for the containment of Bordetella reducing aerogenic transmission.
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings.
- Real-time PCR enables rapid and targeted detection up to 4 weeks after the onset of symptoms and differentiate the human pathogenic Bordetella species.
Clinical Significance
Bordetella pertussis, a gram-negative bacterium, is responsible for the respiratory infection known as pertussis or whooping cough. Other related bacteria such as Bordetella bronchiseptica, Bordetella holmesii, and Bordetella parapertussis can also cause whooping cough or mild symptoms. The transmission of Bordetella infections occurs through droplet infection. Several laboratory diagnostic methods are available, including real-time PCR, culture, and serology. Real-time PCR enables fast and accurate detection of the bacteria up to four weeks after the onset of symptoms, offering sensitivity and specificity.
With the Vivalytic Bordetella test identification of these bacterial strains becomes more accessible, aiding in the prompt initiation of appropriate treatment. This state-of-the-art diagnostic tool enhances the overall efficiency of healthcare practices and contributes to improved patient outcomes with reduced risk of infection for the user.
Features
Sample Type: Nasopharyngeal swab sample
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: 47 minutes
| Detectable Pathogens | ||
|---|---|---|
| B. pertussis | B. parapertussis | B. Holmesii |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Sexually Transmitted Infections ā Rapid Testing at the Point of Care
Urgency, Challenges and Advances in STI Testing
Sexually transmitted infections (STIs) are a major global health issue, with over 30 pathogens causing an estimated one million infections daily, a number that is rising. Surveillance programs in countries like the United States and Canada have reported an increase in STIs such as syphilis, gonorrhoea, and chlamydia. STIs can have serious consequences for sexual health, including infertility and chronic pelvic pain, particularly affecting women. The World Health Organization (WHO) has recognised the urgency of addressing this problem and has recommended measures to end the STI healthcare issue by 2030. Integrated testing, including multiplex and point-of-care testing, is considered essential. However, implementation of these recommendations at regional and national levels is lacking. Rapid point-of-care PCR tests that can detect multiple pathogens simultaneously would greatly improve STI diagnosis and containment. Currently, Randox, in collaboration with Bosch offers two STI test panels on the Vivalytic POC system: Vivalytic STI and Vivalytic MG, MH, UP/UU panels, capable of detecting multiple pathogens in a single test run, with results available within hours.
The Global Burden
- The WHO estimates 374 million new infections of chlamydia, gonorrhoea, syphilis, and trichomoniasis annually.
- Chlamydia is the most frequently reported STI in Europe, followed by gonorrhoea and syphilis.
- Countries with comprehensive STI screening programs, like Denmark, have higher prevalence rates than the European average.
- The UK has a comprehensive screening program for chlamydia targeting 15-24-year-olds, with cases accounting for 60% of total cases in the European Region.
- The actual infection rate in countries without systematic screening is likely higher than official figures suggest.
- Reported cases of gonorrhoea and syphilis in the European Region have increased, particularly among certain age groups and higher numbers in men than women.
Gaps in Current STI Testing Strategies
The European Centre for Disease Prevention (ECDC) acknowledges the growing concern of STIs in Europe and emphasises the importance of testing in their recent report. While various European countries have screening programs for chlamydia, testing options for other STI pathogens are usually limited. The lack of accessible testing, combined with the prevalence of asymptomatic infections, increases the risk of STI transmission and hampers containment efforts. Prevention campaigns and low-threshold testing opportunities are crucial to address the spread of STIs. The UK’s chlamydia screening program, implemented in 2008, demonstrated the benefits of community-based testing services and led to a significant increase in diagnosed cases, reducing the number of unreported cases.
Infections and Co-Infections
- Co-infections, where multiple sexually transmitted pathogens are present simultaneously, are common but often go undetected due to limited testing.
- Symptoms of co-infections can be difficult to differentiate since different pathogens can cause similar or overlapping symptoms.
- However, most STIs, even in high-risk groups, are caused by a single sexually transmitted pathogen.
- In cases where co-infections need to be detected, a rapid and comprehensive differential diagnosis of sexually transmitted pathogens is crucial for initiating appropriate therapy promptly.
The Importance of Rapid Results at the Point of Care
- Rapid detection and treatment of STIs are crucial to prevent further spread.
- Traditional STI diagnostics in specialized laboratories can result in delays of several days or up to 1-2 weeks until test results are available to the physician.
- Delays occur due to transportation of samples, laboratory workflow, result transfer, and scheduling additional appointments.
- The delay in treatment initiation can lead to decreased patient compliance and missed appointments.
The Vivalytic STI test provides results directly at the point of care (POC) in less than two and a half hours. It eliminates the need for sample transportation to a central laboratory. In addition, patients can receive their test results on the same day of the visit, allowing for immediate initiation of appropriate treatment.
In a Nutshell
Sexually transmitted infections (STIs) spread due to various factors. Many STIs do not show symptoms, resulting in numerous unreported and untreated cases that can have fatal consequences depending on the specific pathogen. Increasing awareness and implementing a decentralised low-threshold testing strategy can significantly reduce infections, particularly among high-risk groups. Speed and comprehensive testing of relevant pathogens are crucial for targeted therapy and containing STIs. Rapid PCR tests used at the point of care (POC) are emerging as important technologies due to their advantages. Patients receive same-day results and immediate treatment, providing clarity in just one visit. Clinicians can provide up-to-date diagnoses and treatments, even in decentralised or hospital settings, benefiting high-risk patients with limited access to healthcare.
Vivalytic
The Bosch Vivalytic, is an advanced and automated platform for molecular diagnostics that utilises PCR to detect pathogens. It offers applications for various medical disciplines and requires only a few steps from sample collection to obtaining results. The patient sample is processed automatically within the Vivalytic analyser, and the test result is displayed on its integrated screen. The time it takes to get results depends on the specific Vivalytic application. For the STI Panel, which simultaneously detects 10 common sexually transmitted pathogens, the time to result is 2.5 hours. On the other hand, the Vivalytic MG, MH, UP/UU panel, used to detect mycoplasmas and/or ureaplasmas, provides results in approximately one hour.
By conducting fully automated analyses at the point of care, Vivalytic saves valuable time for hospitals, labs, genitourinary clinics and doctor’s offices during their routine processes.
| STI Panel | MG, MH, UP, UU Panel |
|---|---|
| Chlamydia trachomatis | Mycoplasma genitalium |
| Neisseria gonorrhoeae | Mycoplasma hominis |
| Trichomonas vaginalis | Ureaplasma parvum/Ureaplasma |
| Mycoplasma genitalium | |
| Treponema pallidum | |
| Mycoplasma hominis | |
| Ureaplasma urealyticum | |
| Haemophilus ducreyi | |
| Herpes simplex virus I | |
| Herpes simplex virus II |
At a Glance
- The Vivalytic system allows fully automated sample analysis with minimal manual steps.
- It eliminates the need for expensive and complex laboratory equipment.
- Vivalytic supports both single and multiplex tests.
- The Vivalytic does not require peripheral equipment such as a laptop, keyboard, barcode scanner, or charging station.
- The cartridge used in the system ensures hygienic and safe operation as a closed system.
- Cartridges can be stored and used at room temperature.
- Vivasuite, a cloud-based solution, facilitates convenient device management.
- The Vivalytic can be seamlessly integrated into existing IT structures using HL7, Ethernet, USB, or WLAN.
For more information please contact us at: marketing@randox.com
Internal Quality Control and ISO 15189
As a major contributor to the IVD industry, like many of you, the trials and tribulations of quality control are an everyday consideration. It is for this reason we strive to make the process of IQC as straightforward as possible. We recognise how busy life in the laboratory can get and believe it is our duty to simplify your QC process as much as possible.
The Acusera range has been designed with this in mind. Our true third-party control range boasts unrivalled levels of consolidation, supplied at clinically relevant concentrations in a suitable, commutable matrix. When used in combination with Acusera 24.7, our interlaboratory management software, the Acusera range will help to reduce analytical errors and maximise precision in your laboratory.
With the recent updates to ISO 15189:2022, we understand that there will be added pressure on many laboratories who are trying to maintain their accreditation. To assist you with your gap analysis and transition to these updated standards, we have produced this accreditation guide, detailing all of the key points relating to this new version of the highly sought after accreditation.
If you’d like to find out more about what we can do to help your laboratory or view our range of Internal Quality Controls, don’t hesitate to contact us at marketing@randox.com or feel free to browse the range on our website https://www.randox.com/laboratory-quality-control-acusera/.
Randox Covid-19 Testing: Evaluating the health, social and economic impacts
3rd April 2023: COVID-19 Report Reveals How Randox’s 25 Million PCR Tests Averted Thousands of Hospitalisations and Deaths And Delivered Billions of Pounds Of Economic Benefits
A new report on the work of leading diagnostics company Randox shows that its COVID-19 PCR testing in the public and private sectors averted more than 3,000 UK deaths and 14,100 additional hospitalisations during the pandemic emergency.
That assessment is contained in an evidence-based report into the performance and delivery of Randox during the crisis, compiled by internationally respected economic development consultants OCO Global.
As well as illustrating the impact of PCR testing on deaths and hospitalisations, the report provides an assessment of the wider economic benefit of the test and trace programme.
It reveals that Randox testing delivered £8.3 billion of benefits to the UK economy, by reducing transmission and expediting the return to work for key workers, as well as facilitating social engagement and international travel, crucial to economic recovery.
The report is believed to be one of the most comprehensive analyses of any company awarded government Covid-19 contracts. It will also be provided to the COVID-19 Public Inquiry to assist their considerations regarding future evidence that may be required.
In total, the OCO Global report confirms that Randox processed over 17 million PCR tests as part of the government’s national testing programme between March 2020 and June 2022. The company also provided a further 7.7 million PCR tests plus around 1.8 million lateral flow tests to corporate clients and international travelers.
The report estimates that Randox’s private testing facilitated 4.4 million international return journeys, many of them crucial to support the economy in a time of medical and financial emergency. Other tests supported the nation’s social fabric, enabling people to travel for leisure purposes and to meet families.
The evidence highlights the Northern Ireland-based company’s 40 years experience as one of the world’s leading diagnostic testing companies. This experience, says the OCO report, coupled with the company’s ability and willingness as a private business to innovate and invest its own resources in rapidly upscaling to meet the crisis enabled it successfully to deliver testing on a vast scale. The report also says that innovation in software, automation and robotics, in particular, helped ensure that Randox optimised laboratory efficiency and drove down costs to the benefit of contracting parties.
The report sets out the high level of financial risk taken by Randox during the pandemic and their rapid expansion of laboratories, staff levels and capacity to meet the emergency demand for testing.
In just ten months, Randox increased its capacity to process PCR tests – from 300 tests per day on March 30th 2020, to 120,000 per day by January 2021.
This involved building, equipping and staffing 80,000 square feet of PCR testing laboratory space at the Randox Science Park in County Antrim – the equivalent of a football pitch of new laboratory space.
Overall, the report confirms these improvements and development enabled Randox to deliver 12 per cent of the UK’s PCR testing – and a considerably higher percentage at times when Covid-19 cases, hospitalisations and deaths rocketed to their highest levels. It also notes that the Randox rate of void samples was 15 per cent below the average for the testing programme as a whole.
The report adds: “These improvements would be passed on to the UK Treasury as Randox was able to drive down the cost of testing from £49.60 to £18.00.
“Private individuals also benefited from Randox process improvement as the company was at the forefront of driving down the price of private testing. By October 2021 the cost of a PCR test (click and collect) would be £34.99, a 70 percent decrease from December 2020.” This price included the sample collection kits and all logistics and services, not within the government contracts.
In assessing Randox’s performance the report goes on to say: “Randox is a privately owned company that can make decisions quickly and this proved invaluable in the frenetic early stages of the pandemic when companies and governments across the world were scrambling for supplies and consumables.
“Randox’s willingness to invest came with significant risk: through the majority of the National Testing Programme, Randox were only paid for tests completed and there were no guarantees that payment for the number of tests indicatively contracted for would be received.
“This placed considerable risk with Randox who were having to purchase vast quantities of consumables, despite the uncertainty around how long the pandemic would last or how government policy might change.
“It was this successful risk management which enabled Randox to be one of the best performing laboratories across the National Testing Programme.”
Gareth Hagan, CEO of OCO Global said:
“OCO Global was commissioned by Randox to compile a full, open and comprehensive report into the value of the company’s work, performance and delivery of PCR testing during the pandemic. Randox was a cooperative partner, providing access both to data and to personnel from across the organisation.
“We were able to use external interviews and data sources to corroborate our research. We are satisfied that the facts and the evidence-based findings of our report accurately reflect the work of Randox during the Covid-19 emergency.”
A spokesman for Randox said:
“We believe this report delivers clear evidence of the performance, outcomes and value of the work which Randox is proud to have carried out during one of the greatest peacetime emergencies to have hit the world and the UK.
Editors Notes
Gareth Hagan is interview for media interview
OCO Global is a leading specialist provider of trade and investment services. Headquartered in Northern Ireland, OCO Global has offices in the UK, Ireland, Germany, France, Japan, UAE, China and the U.S.
OCO Global’s clients include leading national, state and regional economic development organizations such as The Department For International Trade (DIT), Enterprise Florida and The Japan External Trade Organization (JETRO), as well as private companies seeking to enter new markets or grow their domestic base, including EY, PWC, Siemens, Smiley Monroe, Pepsico and Santander.
Media Enquiries to Ian Monk /Heather Vernon
Ian.monk@woburnpartners.com +44 7970 026072
Heather.vernon@woburnpartners.com +44 7747 097821
Randox in the media
Latest News
FAQs
Open Day at Randox Teoranta!
We are hosting an open day at Randox Teoranta!
We are delighted to invite you to our careers open day at Randox Teoranta, which will take place on Saturday 8th April from 9.30am to 12.30pm.
This is a fantastic opportunity to discover more about our innovative medical diagnostic technologies and products, as well as to learn about the exciting career opportunities available within our state-of-the-art facility located in Dungloe, Co. Donegal, F94 TV06.
We are Recruiting for these exciting opportunities:
– Engineering Roles
– Scientific Roles
– Manufacturing Roles
– Admin/Support Roles
Come in and see the facility and discuss job opportunities directly with staff. Tea, coffee and traybakes will be available in the morning as well as the chance to win our Easter basket!
Why work at Randox Teoranta?
At Randox Teoranta, we take great pride in fostering a strong company culture that emphasises teamwork, collaboration, and support. We believe that our success is due in large part to the dedicated and motivated individuals who make up our team. Our employees aren’t just colleagues, they’re part of our family. We encourage open communication, provide opportunities for personal and professional growth, and celebrate the achievements of our team members.
Company Culture
Learning Opportunities
At Randox, we offer extensive opportunities for learning and development in various fields such as business, science, design, technology, and engineering. Our fast-paced and forward-thinking work culture values fresh and innovative ideas that can ultimately transform healthcare and save lives.
Whether you’re a full-time employee or a student, Randox Laboratories is a great place to grow and advance in your career. Our highly active placement programs for 1st and 2nd year students in every sector provide 50+ positions each year!
Diagnosing UTI Complications in Mothers and Newborns
Diagnosing UTI Complications in Mothers and Newborns
Urinary tract infections (UTIs) are one of the most common bacterial infections that occur in humans. Over 50% of women become infected with a UTI at least once in their lives, with up to 10% of women suffering from yearly infections5. Recurrence rates are high in UTIs, almost 50% of women who contract a UTI experience reinfection or relapse within one year of the initial infection5. Men are four times less likely to contract a UTI due to a longer urethra seen in men when compared with women.
Infections occur in the urinary organs and structures which can be categorized by the site of infection: cystitis (bladder), pyelonephritis (kidney) and bacteriuria (urine)5. So-called, uncomplicated UTIs are sited only in the bladder, however, UTIs are highly likely to cause secondary infections, commonly in the kidneys. Pyelonephritis has been shown to result in renal scarring and in some cases, subsequent renal failure2. There are various species of bacteria responsible for UTIs, which have different mechanisms of infection and virulence. However, most species have surface adhesins which function like hooks, attaching the bacteria to the urothelial mucosal surface, and colonizing the bladder. From here, the bacteria can ascend the ureters, reaching the kidney and causing secondary infections2.
Under normal conditions, the innate immune system actions an inflammatory response to the infection site. However, some species of bacteria that cause UTI can inhibit or delay the immune response resulting in secondary infections in the ureters and kidneys where the risk of severe renal defects is considerable, and the bacteria have direct access to the bloodstream2.
Common symptoms of UTI include:
- Frequent urination
- Painful urination
- Incomplete voiding of the bladder
- Pelvic, back, and/or abdominal pain
- Haematuria
- Lethargy
- Nausea and/or vomiting
- Fever
Antibiotic therapies are effective and aim to facilitate the immune response and inhibit the spread of the infection to the kidneys and upper urinary tract. Although these treatments are usually effective, antimicrobial resistance (AMR) has become a global crisis encompassing all medical disciplines3. This resistance to antibiotics can occur through several mechanisms such as dysregulation of protein expression, structural modifications, and mutations to name a few11.
Bacteria are capable of some level of intrinsic resistance, or insensitivity, to antibiotics through the production of various enzymes designed to degrade the drug or inhibit its mechanism11. Mutations found in the genome of bacterial species are often responsible for the resistance they display. These mutations commonly alter the bacterial binding sites used by antibiotics, therefore inhibiting their action. Some bacteria produce enzymes, which alter the chemical structure of the antibiotic, again, inhibiting them from binding to the antibiotic. Other examples include horizontal gene transfer and biofilm formation10.
One study reported in 2019, that AMR was the twelfth leading cause of death when compared with a susceptible infection counterfactual9. The same study went on to show that AMR had the highest mortality rate in low to middle-income countries providing evidence that AMR is an even bigger problem in the most impoverished parts of the world. New techniques such as CRISPR-Cas9 and antibiotic re-sensitization methods are at the forefront of the fight against AMR, however, the scale of the problem warrants taking all possible action to elevate the risk posed by AMR8.
UTI During Pregnancy
UTIs are a common occurrence in pregnancy with one hospital reporting over 15% of pregnant women being diagnosed with some form of UTI4. Diagnosis can usually be confirmed by a bacterial growth of over 105 counts/ml in urine4, 12, 13. Many hormonal and anatomical changes occur in a woman’s body during pregnancy that create favorable conditions for UTI. Firstly, the glomerular filtration rate is altered, causing an increase in glucose concentration and pH of the urine3. The urethral dilation, smooth muscle relaxation, enlarged mechanical compression of the uterus, and increased plasma volume result in lower urinary concentration and increased bladder size leading to urinary tract reflux and urine stagnation. These conditions are favorable for the proliferation of bacterial infections1.
Diagnosis of UTIs in pregnant women can be complicated. For example, the increased frequency of urination experienced could also be caused by additional pressure placed on the woman’s bladder by the baby, or the abdominal pain indicative of a UTI could be interpreted as Braxton Hicks contractions and vice versa3. There are several established risk factors associated with UTI in pregnancy including advanced maternal age, diabetes, sickle cell anemia, history of UTI, urinary tract abnormalities, and various immunodeficiencies3. Other reports claim that UTI in pregnancy is more common in women with hypothyroidism and women who are carrying their first child4.
Bacterial Species Responsible for UTI
There are a multitude of bacterial species responsible for UTIs, the most common is Escherichia coli (E. coli), followed by group B streptococcus (GBS), enterococcus, and Klebsiella pneumonia. Escherichia coli infections are categorized as either enteric or extraintestinal (ExPEC). Of the latter, there are two main culprits: neonatal meningitis E. coli (NMEC) and uropathogenic E. coli (UPEC)2. These infections can exist in the gut and spread, colonizing other parts of the host such as the blood or central nervous system, causing other potentially severe infections. Of these strains, UPEC is responsible for around 80% of both symptomatic and asymptomatic UTIs. UPEC strains have been associated with acute renal damage and are thought to encourage bacterial growth and persistence by inhibiting or delaying the innate immune response2.
Maternal and Perinatal UTI Complications
UTI complications in mothers and children have long been debated. However, there is sufficient evidence to support several prognostic claims. Preterm delivery is a major complication associated with UTI and has been well studied. Preterm neonates face a high risk of fatality with up to 1 million babies dying every year due to premature labor6. Those that survive are at risk of developing one or more of the following health defects1:
- Lung problems
- Diabetes
- Heart Disease
- Hearing loss
- Visual impairment
- Learning disabilities
- Behavioral problems
- Cerebral palsy
The risk of preterm birth in women who suffered from a single UTI was increased when compared to women who had no infection during their pregnancy but recurrent UTIs did not increase the risk3. Risk of low birth weight has been shown to increase by 50% in women who suffered symptomatic UTIs compared to those who remained uninfected throughout their pregnancy; this risk can be mitigated through antibiotic therapy. The same treatments did not show any significant ameliorative effects on preterm birth4. Women who contract a UTI during pregnancy are also at a higher risk of various conditions such as preeclampsia, postpartum endometritis, sepsis1, hypertensive disorders, anemia and amnionitis4.
Asymptomatic UTIs, also known as asymptomatic bacteriuria (ASB), are not known to cause as drastic primary effects on pregnancy as seen with symptomatic infections. Despite this, ASB can spread and colonize in the kidneys. At this point, pyelonephritis is likely to occur, increasing the risk of severe renal scarring4 and advanced risk of preterm birth3. In these cases, it is common to treat the patient with antibiotics to reduce the risk of a secondary, symptomatic infection. While these treatments are effective at limiting the progression of the infection, overuse of antibiotics is a primary factor contributing to antimicrobial resistance4.
Screening and Treating UTI Complications
Women who are not pregnant and show no risk factors can be tested for UTI through a simple urine dipstick. The presence of leukocyte and absence of nitrite can be considered a positive UTI diagnosis. However, where complications are likely, a urine culture is required. Cultures can be carried out on blood or MacConkey agar and require preservation of the sample in boric acid, or in a refrigerator, for 24 hours prior to testing. This culture can then be isolated and used to identify the strain of bacteria causing the infection7.
Species identification is imperative in maternal UTIs. Different species have different levels of sensitivity to the various antibiotics available. E. coli, for example, shows 93% sensitivity to Nitrofurantoin but is only 86% sensitive to Fosfomycin. Selection of the correct treatment can ameliorate symptoms rapidly and reduce the possible complications for both mother and baby4. Many species of bacteria known to be responsible for UTIs have displayed resistance to antibiotics. Group B streptococcus has been shown to be 42% resistant to clindamycin4. The selection of antibiotics available to clinicians treating maternal UTI are already limited as many antibiotics have been associated with increased risk of miscarriage and birth defects independent of UTI1.
With the patient in mind, Randox provides clinicians with both laboratory and near patient testing solutions. Bringing to the market, to help eliminate distress and improve testing turnaround times, the Randox Urinary Tract Infection Array. It has the ability to detect 30 bacterial, fungal, and associated antibiotic resistance markers from a single urine sample in under four hours. This multiplex diagnostic tool can help detect specific bacterial and fungal strains known to cause UTI allowing laboratories to confidently diagnose patients in a timely manner, aiding with targeted treatments and helping to reduce risk of complications.
The Ongoing UTI Battle
Maternal UTI is a very common problem resulting in many fatalities and morbidities worldwide. It is crucial to identify and characterize these infections to limit the negative effects seen to both mothers and their children. Quick and efficient screening is paramount in the battle against bacteria to allow the prescription of targeted treatment. While antibiotics are often an effective weapon against UTIs, care should be taken when prescribing these treatments to pregnant women due to the potential adverse effects that have been reported. Furthermore, unnecessary treatments using antibiotics should be avoided at all costs due to the increasingly serious issue of antimicrobial resistance.
References
1.Eslami V, Belin S, Sany T, Ghavami V, Peyman N. The relationship of health literacy with preventative behaviours of urinary tract infection in pregnant women. Journal of Health Literacy. 2022;6(4):22-31. doi:https://doi.org/10.22038/jhl.2021.59768.1183
2.Bien J, Sokolova O, Bozko P. Role of Uropathogenic Escherichia coli Virulence Factors in Development of Urinary Tract Infection and Kidney Damage. International Journal of Nephrology. Published online 2012:1-15. doi:https://doi.org/10.1155/2012/681473
3.Werter DE, Kazemier BM, van Leeuwen E, et al. Diagnostic work-up of urinary tract infections in pregnancy: study protocol of a prospective cohort study. BMJ Open. 2022;12(9):e063813. doi:https://doi.org/10.1136/bmjopen-2022-063813
4.Balachandran L, Jacob L, Al Awadhi R, et al. Urinary Tract Infection in Pregnancy and Its Effects on Maternal and Perinatal Outcome: A Retrospective Study. Cureus. 2022;14(1). doi:https://doi.org/10.7759/cureus.21500
5.Bono MJ, Reygaert WC. Urinary Tract Infection. Nih.gov. Published 2018. https://www.ncbi.nlm.nih.gov/books/NBK470195/
6.World Health Organization. Preterm birth. Who.int. Published February 19, 2018. Accessed February 8, 2023. https://www.who.int/news-room/fact-sheets/detail/preterm-birth
7.Sinawe H, Casadesus D. Urine Culture. PubMed. Published 2021. https://www.ncbi.nlm.nih.gov/books/NBK557569/
8.Schrader SM, Botella H, Vaubourgeix J. Reframing antimicrobial resistance as a continuous spectrum of manifestations. Current Opinion in Microbiology. 2023;72:102259. doi:https://doi.org/10.1016/j.mib.2022.102259
9.Murray CJ, Ikuta KS, Sharara F, et al. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:https://doi.org/10.1016/S0140-6736(21)02724-0
10.Ali J, Rafiq QA, Ratcliffe E. Antimicrobial resistance mechanisms and potential synthetic treatments. Future Science OA. 2018;4(4):FSO290. doi:https://doi.org/10.4155/fsoa-2017-0109
11.Nelson DW, Moore JE, Rao JR. Antimicrobial resistance (AMR): significance to food quality and safety. Food Quality and Safety. 2019;3(1):15-22. doi:https://doi.org/10.1093/fqsafe/fyz003
12.Myers AL. Curbside Consultation in Pediatric Infectious Disease : 49 Clinical Questions. Slack; 2012:4.
13.Oie S, Kamiya A, Hironaga K, Koshiro A. Microbial contamination of enteral feeding solution and its prevention. American Journal of Infection Control. 1993;21(1):34-38. doi:https://doi.org/10.1016/0196-6553(93)90205-i
7. Sinawe H, Casadesus D. Urine Culture. PubMed. Published 2021. https://www.ncbi.nlm.nih.gov/books/NBK557569/
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WorldlabāEuromedlab 2023
We will be exhibiting at Worldlab∙Euromedlab 2023!
We invite you to stop by RCC La Nuvola in Rome between May 21st and May 25th, 2023 for a visit.
Make sure to drop by Booth #153, where we’ll be engaging in conversations about cutting-edge diagnostic products and solutions, while also showcasing our groundbreaking technologies.
With over four decades of experience in the medical diagnostics industry, Randox is dedicated to enhancing global health outcomes. As a provider of high-quality diagnostic solutions, Randox offers a wide range of products and services, including Quality Control, Molecular Diagnostics, Third Party Reagents, Point of Care, and Clinical Chemistry Analysers.
